Key Facts

Remote From:

Full time

Mid-level (2-5 years)

English

Hard Skills

Clinical Monitoring Clinical Trial Planning Data Management Budget Management Regulatory Compliance Vendor Management File Management Feasibility Studies Protocol Implementation Conformance Statement Project Coordination +5 more

Other Skills

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Communication
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Teamwork
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Organizational Skills
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Detail Oriented

Roles & Responsibilities

University Master's degree in healthcare or a related field
Minimum 2 years' CRA experience, including Phase I trials
Understanding of regulatory guidelines and compliance
Fluency in English and the local language (written and spoken) with strong computer skills

Requirements:

Conduct routine, pre-study, initiation, and close-out site visits for Phase I trials to ensure adherence to project plans
Site and patient protection duties, including informed consent, protocol adherence, regulatory compliance, and SAE tracking with follow-up
Data quality oversight through source data verification, CRF review, and management of data queries to ensure accuracy and completeness
Operational site management and cross-functional coordination, including trip reports, audit readiness, study file maintenance, vendor coordination, and internal team collaboration

Job description

Fortrea is looking for Clinical Research Associates (CRAs) in Portugal to support early-phase (Phase I) clinical trials, offering the opportunity to work on innovative, first-in-human studies in a dynamic environment.

Main Responsibilities:

Clinical site monitoring: conducts routine, pre‑study, initiation, and close‑out visits, ensuring full compliance with project plans.
Site and patient protection: ensures informed consent, protocol adherence, and regulatory compliance to safeguard study participants.
Data quality oversight: performs source document verification, CRF review, and manages data queries to ensure accuracy and completeness.
Operational site management: prepares trip reports, ensures audit readiness, manages study files, coordinates with vendors, and uses resources efficiently.
Safety reporting: tracks and follows up on Serious Adverse Events (SAEs), supporting report and narrative preparation.
Extended support activities: feasibility assessments, QC visits, EC submissions, budget support, training/mentoring of new staff, and local project coordination.
Cross‑functional communication & logistics: liaises with internal teams, manages study materials, and travels as required.

Qualifications required:

University Master's degree in healthcare or similar.
Basic understanding of the clinical trial process and foundational knowledge of applicable regulatory guidelines.
Fluency in both English and the local office language, in written and verbal communication.

Experience (Minimum Required):

• Mandatory 2 year minimum of experience as CRA.

• Mandatory experience in Phase I trials.

• Understanding of Regulatory Guidelines.

• Good computer skills with good working knowledge of a range of computer packages.

By stepping into this role, you’ll join a highly collaborative, supportive, and growth‑oriented environment where your development is valued and your contributions truly make an impact

Learn more about our EEO & Accommodations request here.